Description

Aprepitant Ep Impurity C CAS NO 2348441-63-2 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the antiemetic drug Aprepitant by serving as a known impurity marker. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method validation, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of Aprepitant Ep Impurity C in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies of Aprepitant to understand degradation pathways and establish shelf-life.
• Quality Control (QC) Testing: Essential for routine QC release testing of Aprepitant API to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research and Development: Utilized in synthetic chemistry R&D to study the formation and fate of this specific impurity during the API synthesis process.

Basic Information

Item	Details
Product Name	Aprepitant Ep Impurity C
CAS No.	2348441-63-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound C; Aprepitant Impurity C; Fosaprepitant Impurity C; (3R,5S)-5-[(2R)-1-[3,5-Bis(trifluoromethyl)benzyl]-2-(4-fluorophenyl)-4-(morpholin-4-yl)piperidin-3-yl]-5-methyl-1,3-oxazolidin-2-one; Aprepitant EP Impurity C; MK-0869 Impurity C; Emend Impurity C; L-754030 Impurity C
EINECS	Contact for details

Quality Control

Our Aprepitant Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing identity, purity, and impurity profiles, ensuring compliance with relevant pharmacopeial guidelines (EP, USP) and ICH Q3A/B requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.